Computerized HIV/Sexually Transmitted Disease (STD) Prevention Program (TIPSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Kentucky.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00947947
First received: July 24, 2009
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The purpose of the current study is to test a computerized HIV/STD prevention program with heterosexual African Americans. The hypothesis is that those exposed to the program will increase their correct and consistent use of condoms compared to those not exposed to the program.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
HIV Infections
Behavioral: Tailored Information Program for Safer Sex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Enhancing Message Design in Tailored, Computerized HIV/STI Interventions

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Condom use with main and casual sexual partners [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Tailored Information Program for Safer Sex
    Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.
    Other Name: Computerized health intervention
Detailed Description:

The proposed study will involve the development and pilot testing of an interactive computerized tailored intervention program for HIV/STI prevention among at-risk heterosexually active African-American STI clinic patients, aged 18-29. The Attitude-Social-Influence Efficacy model will serve as a conceptual foundation for the intervention and tailored feedback, which will assess and give feedback to participants separately for main/steady and other/casual partners. Individual modules will be developed for key theoretical concepts and subsequently tied together into an integrated system. The tailored feedback will additionally be enhanced by crafting intervention messages to be high in message sensation value and by developing interactive intervention activities for skill-building, which will be guided by both Social Cognitive Theory and skills training principles. The computerized intervention will be developed and guided using data collected from the target audience to ensure an empirically-based approach to tailoring. The intervention will also be developed with input from the target audience in order to maximize the appropriateness and persuasiveness of the feedback and the program, including interactive components. The final year of the project will entail a pilot test of the intervention in order to gather preliminary data on the acceptability and efficacy of such an intervention for increasing safer sexual behaviors among at-risk heterosexually active African-Americans.

The specific aims of the study are: 1) to develop tailored feedback on HIV/STI prevention based on the ASE model, including condom attitudes, social influences, self-efficacy including communication / negotiation skills, partner and behavioral risk, correct condom use, and condom stages of change; 2) to enhance the delivery of the tailored messages using sensation-seeking targeting (SENTAR) and skill-building using interactive activities guided by Social Cognitive Theory (SCT) and skills training principles; 3) to tie the individual theoretical modules together and develop a computerized intervention program for HIV/STI prevention, which provides tailored risk reduction messages to participants based upon an assessment of participant characteristics; 4) to develop empirically sound cutpoints, specific to the target audience, to guide the message tailoring; and 5) in a wait-list control group design, to pilot test the intervention for acceptability and efficacy in increasing condom use with main and casual partners among at-risk heterosexually active African-Americans, relative to a "usual care" comparison condition.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • Aged 18-29
  • Heterosexually active in past 3 months
  • NOT knowingly HIV positive
  • Not pregnant or planning on becoming pregnant/impregnating partner in next 3 months
  • Client of the STI clinic where study is being conducted
  • Not currently enrolled in another condom study at the clinic

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947947

Contacts
Contact: Seth M Noar, Ph.D. 859-257-7809 noar@uky.edu
Contact: Elizabeth Webb, M.A. 859-257-1605 emwebb@uky.edu

Locations
United States, Kentucky
Specialty Clinic, Louisville Metro Health Department Recruiting
Louisville, Kentucky, United States, 40204
Contact: Seth Noar, PhD     859-257-7809     noar@uky.edu    
Contact: Stephanie Van Stee, MA     859-257-1605     stephanievanstee@gmail.com    
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Seth M Noar, Ph.D. Department of Communication, University of Kentucky
  More Information

No publications provided

Responsible Party: Deborah Davis, University of Kentucky Research Foundation
ClinicalTrials.gov Identifier: NCT00947947     History of Changes
Other Study ID Numbers: R34-MH077507
Study First Received: July 24, 2009
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
condom use
HIV prevention
African American
Behavioral intervention
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on March 14, 2013